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510(k) Data Aggregation

    K Number
    K052892
    Device Name
    SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
    Manufacturer
    BARRIERMED GLOVE CO.
    Date Cleared
    2005-11-30

    (47 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Synthalon® PC Plus Powder-free Polychloroprene Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Synthalon® PC Plus Powder-free Polychloroprene Examination Glove

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical glove. It does not contain information about acceptance criteria or a study proving device performance in the way typically expected for an AI/ML medical device.

    Therefore, I cannot provide the requested table and study details. The document is a regulatory approval for a physical medical device (examination glove) based on substantial equivalence to a predicate device, not on clinical performance metrics or AI algorithm evaluation.

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